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The immunogenicity of MENVEO was evaluated 1 month after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 1 month after a dose of either MENVEO or Menactra.1

Seroresponse was defined as:

A postvaccination hSBA ≥1:8 for subjects with a prevaccination hSBA <1:4 or

At least a 4-fold increase above baseline titers for subjects with a prevaccination hSBA ≥1:4

For all 4 serogroups (A, C, W-135, and Y), noninferiority criteria for MENVEO compared to Menactra were met.1

MENVEO does not prevent N. meningitidis serogroup B infections.

SERORESPONSE RATES AT 1 MONTH POSTVACCINATION IN ADOLESCENTS 11-18 YEARS OF AGE1,*

SEE THE RELATIVE GMT RATES VS MENACTRA1

This head-to-head study also measured geometric mean titers (GMTs) in subjects 1 month after a dose of either MENVEO or Menactra in 11 to 18 year-olds. GMTs are a measure of the level of immune response to a vaccine in a specific study group.1

The point estimates for fold differences in GMTs between MENVEO and Menactra are >1 for all 4 serogroups, although for serogroup C the confidence interval includes 1. The clinical significance of these differences is unknown.1

Seroresponse was defined as a postvaccination hSBA ≥1:8 for subjects with a prevaccination hSBA <1:4, or at least a 4-fold increase higher than baseline titers for subjects with a prevaccination hSBA ≥1:4.

†

GMTs are a measure of the level of immune response to a vaccine in a specific study group. GMTs for MENVEO were evaluated at 1 month postvaccination.

Randomized, multicenter, active-controlled study in healthy adolescents 11-18 years of age. Subjects were randomized to receive 1 dose of MENVEO or Menactra. Noninferiority criterion for the primary endpoint was met for all serogroups (lower limit of the 2-sided 95% CI ≥10% for vaccine group differences [MENVEO minus Menactra]). In separate studies, for the proportion of subjects with a seroresponse, noninferiority criterion was met for serogroups C, W-135, and Y but not for serogroup A in subjects 2-5 and 6-10 years of age, and was met for all serogroups in subjects 19-55 years of age.

INDICATION

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.

IMPORTANT SAFETY INFORMATION FOR MENVEO

Severe allergic reaction (eg, anaphylaxis) after a previous dose of MENVEO, any component of this vaccine, or any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine is a contraindication to administration of MENVEO

Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO

Syncope, sometimes resulting in falling injury associated with seizure-like movements, has been reported following vaccination with MENVEO. Vaccinees should be observed for at least 15 minutes after vaccine administration to prevent and manage syncopal reactions

Safety and effectiveness of MENVEO have not been evaluated in immunocompromised persons. If MENVEO is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer MENVEO to subjects with a known history of GBS should take into account the potential benefits and risks

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including MENVEO, to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination

In clinical trials, common solicited adverse reactions with MENVEO among children initiating vaccination at 2 months of age and receiving the four-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea. Common solicited adverse reactions among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea. Common solicited adverse reactions among children 2 years through 10 years of age were injection-site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults were pain at the injection site, headache, myalgia, malaise, and nausea. Some events were severe

Safety has not been established in pregnant women

Vaccination with MENVEO may not result in protection in all vaccine recipients

References

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967